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National Coverage Analysis (NCA) Tracking Sheet for Implantable Cardioverter Defibrillators (CAG-00157R4)

An implantable cardioverter defibrillator (ICD) is an electronic device designed to diagnose and treat life-threatening ventricular tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.

Section 20.4 of the Medicare National Coverage Determinations (NCD) Manual establishes conditions of coverage for implantable cardioverter defibrillators. In 1986 CMS first issued an NCD providing limited coverage of implantable defibrillators and the policy has been expanded over the years. CMS last reconsidered this NCD in 2005.

CMS is opening this national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators.

Prosthetic Devices
Requestor Name(s)Internally generated
Formal Request Accepted and Review Initiated05/30/2017
Expected NCA Completion Date02/20/2018
Public Comment Period05/30/2017 - 06/29/2017
Proposed Decision Memo Released11/20/2017
Proposed Decision Memo Public Comment Period11/20/2017 - 12/20/2017 
Decision Memo Released02/15/2018
Comments for this NCAView Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • Joseph Hutter, MD, MA

May 30, 2017

CMS initiates this national coverage analysis for reconsideration of Section 20.4 of the NCD Manual. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.

CMS considers all public comments and is particularly interested in comments that include clinical studies and other scientific evidence.

Instructions on submitting public comments can be found at https://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

November 20, 2017

February 15, 2018

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